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Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus (Apricity-A Trial)

Phase 3
Recruiting
Research Sponsored by Epion Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosis of keratoconus
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a treatment called Epithelium-On Corneal Cross-linking for people aged 8 to 45 who have Keratoconus. The treatment uses special eye drops and light to make the cornea stronger. The goal is to see if this method is safe and effective in stopping the cornea from getting worse. Corneal cross-linking using riboflavin and ultraviolet-A light has been widely adopted and refined to treat keratoconus by increasing the biomechanical strength of the cornea.

Eligible Conditions
  • Keratoconus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
Secondary study objectives
Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
Epithelium-on corneal cross-linking
Group II: Control TreatmentPlacebo Group1 Intervention
Placebo and sham for epithelium-on corneal cross-linking

Find a Location

Who is running the clinical trial?

Epion TherapeuticsLead Sponsor
1 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Keratoconus
400 Patients Enrolled for Keratoconus
Michael Belin, MDStudy DirectorEpion Therapeutics
1 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Keratoconus
400 Patients Enrolled for Keratoconus
~157 spots leftby Oct 2025
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